Pharmedium Recalls Dexamethasone Sodium Phosphate Due to Sterility Assurance Issues
Pharmedium Services, LLC is recalling Dexamethasone Sodium Phosphate in all strengths and packaging due to a lack of sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Pharmedium Services, LLC is recalling Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. The recall is being conducted because of a lack of sterility assurance. The affected product is distributed nationwide in the United States.
The recall includes all lots of the product that remain within their expiration dates. The source text does not specify the number of units affected or the specific dates of distribution.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. The source text does not provide specific contact information for the recalling firm.
The recalled product
- Product
- Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Steroids
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
Same manufacturer · Pharmedium Services, LLC
See all →- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SevereDexamethasone Solution Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2014-01-22
- SevereDexamethasone phosphate injection recalled for lack of sterility assurance
FDA (Drugs) · 2014-03-12
- SevereGreen Valley Drugs Recalls Dexamethasone Sodium Phosphate Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- SeverePharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
FDA (Drugs) · 2017-07-26
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SevereBetamethasone Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2013-05-01